Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of the study were to determine whether ondansetron treatment would reduce:

• the amount of vomiting in the emergency department;

• the need for intravenous rehydration; and

• the need for hospitalization.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; GlaxoSmithKline; National Center for Research Resources (NCRR)
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Acute gastroenteritis

• Non-bilious and non-bloody vomiting within 4 hours of triage

• Diarrhea

• Mild to moderate dehydration

Exclusion Criteria:

• Weight less than 8 kilograms

• Severe dehydration

• Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)

• History of abdominal surgery

• Hypersensitivity to the drug or any components in its formulation